Approval Order StatementApproval of new labeling that will present the specificity of cad marks generated by r2 imagechecker computer aided detection system as well as its ability to mark actionable priors. The indications for use remain as previously approved: the imagechecker m5000 is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.